Agency's proposed research plan has numerous defects, groups complain

The proposed Centers for Medicare and Medicaid Services' (CMS) plan for coverage of the Watchman left atrial appendage (LAA) closure device shouldn't require a registry control arm and should adjust performance and patient selection criteria, a trio of professional societies argued.

The Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the Heart Rhythm Society (HRS) sent those requests in a letter to CMS Thursday, shortly after publishing a consensus statement on institutional and operator requirements for LAA closure.

The Registry

The consensus document, published online in the flagship journals of the three societies, agreed on mandatory participation in a national registry for all LAA closure procedures.

"For this population, the term 'control' is inaccurate," the presidents of the three societies wrote. "The 'non-interventional controls' would in fact represent a widely mismatched group that should not be comparable to patients who receive the device. The societies strongly object to this requirement and recommend its deletion."

"Moreover," they added, "such a control arm would require that every institution performing LAAC set up an elaborate screening process, obtain investigational review board approval, and seek informed consent from patients and follow up from patients, most of whom may be seen entirely in an outpatient setting by a myriad of clinicians few of whom will have any involvement with LAAC."

The letter said the "two well conducted trials that randomized patients" that have been done provide better data than such a registry comparison ever could.

However, CMS wasn't convinced by the available trials. Its draft document said coverage would have to be in the research setting because the evidence hasn't shown Watchman use is "reasonable and necessary" for stroke prevention in nonvalvular atrial fibrillation.

A registry has already been developed, a dataset in the ACC's National Cardiovascular Data Registry (NCDR) LAA Occlusion Registry, albeit with more limited stroke adjudication than CMS proposed.

The Requirements

CMS and the societies also differed on criteria for performance.

The CMS proposal required no institutional case volume but that the primary implanting physician have performed at least 25 interventional cardiac procedures involving transseptal puncture, with at least 10 in the prior 12 months, and be an interventional cardiologist or electrophysiologist.

By contrast, the consensus document emphasized institutional experience, setting out the following:

Institutions should have done at least 50 structural heart disease or left-sided catheter ablations, with at least 25 involving transseptal puncture through an intact septum, in the year prior to starting a LAA closure program.

Procedures should be done in a cardiac catheterization laboratory, electrophysiology suite, or hybrid suite and have quality imaging available.

Operators should also have a detailed understanding of the left atrium and LAA as well as experience with left-sided cardiac access.

William W. O'Neill, MD, an interventional cardiologist at Henry Ford Hospital in Detroit, called the ACC/HRS/SCAI standards "reasonable" in ensuring safety of the procedure.

"With any new technology, quick widespread dissemination is fraught with risk for complications," and LAA closure has an important learning curve, he told MedPage Today by email. He noted, though, that he would have liked to have seen more emphasis on transesophageal echocardiography guidance for transseptal puncture in the document.

Clifford J. Kavinsky, MD, PhD, chair of the writing committee for the document, suggested that the criteria selected should leave enough centers in every geographic region of the country to provide access for patients.

"Our recommendations are made in name of patient-centered care to ensure the safety and efficacy of this technology," he said. "We went as lenient as we could be so as not to be exclusionary."

His group also disagreed with CMS that proctors supervising operators' first procedures should not be industry representatives or paid by industry for those activities. He fretted that the CMS requirement would be impossible to meet.

"Being practical, as we move into this technology, the only operators that are out there are ones who participated in the randomized controlled trials, which were sponsored by a single company," he told MedPage Today in an interview. "How will we obtain proctors who have no relationship with the sponsor? And what proctor would come if they are not compensated for their time and effort?"

Patient Selection Criteria

The societies called for CMS to specify what is meant by "high" CHADS2 or CHA2DS2-VASc score as 2 or greater and 3 or greater, respectively, and "high" HAS-BLED score as 3 or higher.

But the key contention was CMS' requirement that patients have a contraindication to warfarin, which goes against the FDA indication for Watchman that specified it be used in patients able to take the anticoagulant.

"They have to at least include the people with an FDA indication," Kavinsky argued.

"CMS has since clarified that the FDA label is broader than the proposed Medicare coverage determination, but that Medicare proposes to cover what the FDA approved and not any off-label use," she wrote. "It appears that CMS simply wants to ensure that the device is 'necessary,' not just a convenient replacement for the need to take daily pills."

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